Glaxo’s Darapladib Fails to Prevent Heart Attacks in Test

GlaxoSmithKline Plc (GSK) said darapladib
drug for preventing plaque ruptures failed to meet the primary
goal of a late-stage study of more than 15,000 patients with
chronic coronary heart disease.

The medicine didn’t lower the risk of heart attack or
stroke, according to a study that tracked participants since
December 2008, London-based Glaxo said in a statement today.
Patients took darapladib or a placebo in addition to a
cholesterol-lowering statin. The drugmaker said it will review
the data, which indicated that some subgroups benefited, and
await the results of a second late-stage study in acute coronary
syndrome before deciding what the next steps will be.

Darapladib was developed with Human Genome Sciences Inc.,
which Glaxo bought last year for $3 billion. The treatment
failed in a mid-stage study to meet the primary goal of getting
rid of plaque. Glaxo proceeded with the late-stage trial anyway
on the basis that the drug showed promise in lowering the risk
of plaque rupturing and causing a heart attack.

The drug was developed for patients who aren’t helped
enough by statins, a class of cholesterol-lowering medicines
that includes Pfizer Inc.’s Lipitor and AstraZeneca Plc’s
Crestor. About 12 million people in the U.S. and 21 million
worldwide don’t achieve the recommended reduction in LDL
cholesterol with statins, according to a presentation last year
by Sanofi, which is also developing a new drug to reduce
cholesterol.

Stock Declines

Glaxo fell as much as 1.3 percent, the steepest intraday
decline since Oct. 23, and was trading down 1.1 percent at
1,632.5 pence at 8:28 a.m. in London. That pared the stock’s
gain this year to 22 percent, valuing the drugmaker at 79.4
billion pounds ($127 billion).

The trial had 20 percent chance of success, according to
Andrew Whitney, an analyst at UBS AG. He estimates that
darapladib could generate 604 million pounds in sales by 2017,
should it reach the market.

Heart disease and stroke are the two biggest causes of
death worldwide, accounting for almost 22 percent of deaths in
2011, according to the Geneva-based World Health Organization.
The low-density lipoprotein, or LDL, form of cholesterol only
comes from eating animal products, and it raises the risk of the
two illnesses by clogging arteries, according to the American
Heart Association.